82 FR 41624 - Electronic Study Data Submission; Data Standards; Support End Date for Study Data Tabulation Model Version 1.2, Implementation Guide Version 3.1.2, and Implementation Guide Version 3.1.2, Amendment 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 169 (September 1, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 169 (September 1, 2017)
| Page Range | 41624-41625 | |
| FR Document | 2017-18566 |
[Federal Register Volume 82, Number 169 (Friday, September 1, 2017)] [Notices] [Pages 41624-41625] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-18566] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-4302] Electronic Study Data Submission; Data Standards; Support End Date for Study Data Tabulation Model Version 1.2, Implementation Guide Version 3.1.2, and Implementation Guide Version 3.1.2, Amendment 1 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) are announcing the end of support for Version 1.2 of Clinical Data Interchange Standards Consortium Study Data Tabulation Model (SDTM) and an [[Page 41625]] update to the FDA Data Standards Catalog. FDA will continue its support of the newer SDTM Version 1.3 and Version 1.4, which have been listed in the FDA Data Standards Catalog since December 2012 and August 2015, respectively. FDA support for SDTM Version 1.2 will end for studies that start 12 months after March 15, 2018. DATES: Submit either electronic or written comments at any time. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2017-N-4302 for ``Electronic Study Data Submission; Data Standards, Support End Date for Study Data Tabulation Model Version 1.2, Implementation Guide Version 3.1.2, and Implementation Guide Version 3.1.2, Amendment 1.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Fatima Frye, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1192, Silver Spring, MD 20993-0002, 301- 796-4863, email: [email protected]; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7268, Silver Spring, MD 20993-0002, 240-402-7911, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background On December 17, 2014, FDA published final guidance for industry ``Providing Regulatory Submissions in Electronic Format--Standardized Study Data'' (eStudy Data guidance) posted on FDA's Study Data Standards Resources Web page at https://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm. The eStudy Data guidance implements the electronic submission requirements of section 745A(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379k-1(a)) for study data contained in new drug applications, abbreviated new drug applications, biologics license applications, and investigational new drug applications submitted to CDER or CBER by specifying the format for electronic submissions. The eStudy Data guidance states that a Federal Register notice will specify the transition date for updates to standards (with the month and day for the transition date corresponding to March 15). The transition date for the end of FDA support for SDTM Version 1.2, Implementation Guide Version 3.1.2, and Implementation Guide Version 3.1.2, Amendment Version 1.2 is March 15, 2018. Therefore, FDA support for SDTM Version 1.2, Implementation Guide Version 3.1.2, and Implementation Guide Version 3.1.2, Amendment 1.2 will end for studies that start after March 15, 2019. The FDA Data Standards Catalog (see https://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm) will be updated to list March 15, 2019, as the ``date support ends.'' II. Electronic Access Persons with access to the internet may obtain the referenced material at https://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm. Dated: August 29, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-18566 Filed 8-31-17; 8:45 am] BILLING CODE 4164-01-P
![41624 Federal Register / Vol. 82, No. 169 / Friday, September 1, 2017 / Notices
owners, suppliers, and employees, as gain approval of a new drug application reasons of safety or effectiveness. We
well as recommendations on how to (NDA). have carefully reviewed our files for
ensure that disadvantaged communities The 1984 amendments include what records concerning the withdrawal of
are not denied the wide range of is now section 505(j)(7) of the Federal NIZORAL (ketoconazole) tablets, 200
opportunities made possible by next- Food, Drug, and Cosmetic Act (21 U.S.C. mg, from sale. We have also
generation networks. This agenda may 355(j)(7)), which requires FDA to independently evaluated relevant
be modified at the discretion of the publish a list of all approved drugs. literature and data for possible
ACDDE Chair and the DFO. FDA publishes this list as part of the postmarketing adverse events. We have
‘‘Approved Drug Products With reviewed the available evidence and
Federal Communications Commission.
Therapeutic Equivalence Evaluations,’’ determined that this drug product was
Thomas Horan,
which is known generally as the not withdrawn from sale for reasons of
Chief of Staff, Media Bureau. ‘‘Orange Book.’’ Under FDA regulations, safety or effectiveness.
[FR Doc. 2017–18550 Filed 8–31–17; 8:45 am] drugs are removed from the list if the Accordingly, the Agency will
BILLING CODE 6712–01–P Agency withdraws or suspends continue to list NIZORAL
approval of the drug’s NDA or ANDA (ketoconazole) tablets, 200 mg, in the
for reasons of safety or effectiveness or ‘‘Discontinued Drug Product List’’
DEPARTMENT OF HEALTH AND if FDA determines that the listed drug section of the Orange Book. The
HUMAN SERVICES was withdrawn from sale for reasons of ‘‘Discontinued Drug Product List’’
safety or effectiveness (21 CFR 314.162). delineates, among other items, drug
Food and Drug Administration A person may petition the Agency to products that have been discontinued
determine, or the Agency may from marketing for reasons other than
[Docket No. FDA–2017–N–5079] determine on its own initiative, whether safety or effectiveness. FDA will not
a listed drug was withdrawn from sale begin procedures to withdraw approval
Determination That NIZORAL for reasons of safety or effectiveness. of approved ANDAs that refer to
(Ketoconazole) Tablets, 200 Milligrams, This determination may be made at any NIZORAL. Additional ANDAs that refer
Were Not Withdrawn From Sale for time after the drug has been withdrawn to NIZORAL (ketoconazole) tablets, 200
Reasons of Safety or Effectiveness from sale, but must be made prior to mg, may also be approved by the
AGENCY: Food and Drug Administration, approving an ANDA that refers to the Agency as long as they meet all other
HHS. listed drug (§ 314.161 (21 CFR 314.161)). legal and regulatory requirements for
FDA may not approve an ANDA that the approval of ANDAs. If FDA
ACTION: Notice.
does not refer to a listed drug. determines that labeling for this drug
SUMMARY: The Food and Drug NIZORAL (ketoconazole) tablets, 200 product should be revised to meet
Administration (FDA or Agency) has mg, is the subject of NDA 018–533 and current standards, the Agency will
determined that NIZORAL was originally held by Johnson & advise ANDA applicants to submit such
(ketoconazole) tablets, 200 milligrams Johnson Research and Development, labeling.
(mg), were not withdrawn from sale for L.L.C., now known as Janssen Research Dated: August 28, 2017.
reasons of safety or effectiveness. This & Development, L.L.C. (Janssen). It was
Anna K. Abram,
determination means that FDA will not initially approved on June 12, 1981.
NIZORAL should be used only when Deputy Commissioner for Policy, Planning,
begin procedures to withdraw approval Legislation, and Analysis.
of abbreviated new drug applications other effective antifungal therapy is not
available or tolerated and the potential [FR Doc. 2017–18548 Filed 8–31–17; 8:45 am]
(ANDAs) that refer to NIZORAL, and it BILLING CODE 4164–01–P
will allow FDA to continue to approve benefits are considered to outweigh the
ANDAs that reference NIZORAL as long potential risks. NIZORAL is indicated
as they meet relevant legal and for the treatment of the following
systemic fungal infections in patients DEPARTMENT OF HEALTH AND
regulatory requirements. HUMAN SERVICES
who have failed or who are intolerant to
FOR FURTHER INFORMATION CONTACT: other therapies: blastomycosis,
Robin Fastenau, Center for Drug Food and Drug Administration
coccidioidomycosis, histoplasmosis,
Evaluation Research, Food and Drug chromomycosis, and [Docket No. FDA–2017–N–4302]
Administration, 10903 New Hampshire paracoccidioidomycosis.
Ave., Bldg. 51, Rm. 6236, Silver Spring, In a letter dated May 22, 2008, Electronic Study Data Submission;
MD 20993–0002, 240–402–4510. Janssen, which at that time was Data Standards; Support End Date for
SUPPLEMENTARY INFORMATION: In 1984, operating as Johnson & Johnson Study Data Tabulation Model Version
Congress enacted the Drug Price Pharmaceutical Research & 1.2, Implementation Guide Version
Competition and Patent Term Development, L.L.C., acting on behalf of 3.1.2, and Implementation Guide
Restoration Act of 1984 (Pub. L. 98–417) Ortho-McNeil-Janssen Pharmaceuticals, Version 3.1.2, Amendment 1
(the 1984 amendments), which Inc., notified FDA that NIZORAL AGENCY: Food and Drug Administration,
authorized the approval of duplicate (ketoconazole) tablets, 200 mg, were HHS.
versions of drug products under an being discontinued and requested ACTION: Notice.
ANDA procedure. ANDA applicants withdrawal of NDA 018–533. In the
must, with certain exceptions, show that Federal Register of October 13, 2015 (80 SUMMARY: The Food and Drug
the drug for which they are seeking Administration’s (FDA or Agency)
sradovich on DSK3GMQ082PROD with NOTICES
FR 61426), FDA announced that it was
approval contains the same active withdrawing approval of NDA 018–533, Center for Biologics Evaluation and
ingredient in the same strength and effective November 12, 2015. Research (CBER) and Center for Drug
dosage form as the ‘‘listed drug,’’ which After reviewing Agency records and Evaluation and Research (CDER) are
is a version of the drug that was based on the information we have at this announcing the end of support for
previously approved. ANDA applicants time, FDA has determined under Version 1.2 of Clinical Data Interchange
do not have to repeat the extensive § 314.161 that NIZORAL (ketoconazole) Standards Consortium Study Data
clinical testing otherwise necessary to tablets, 200 mg, were not withdrawn for Tabulation Model (SDTM) and an
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![Federal Register / Vol. 82, No. 169 / Friday, September 1, 2017 / Notices 41625
update to the FDA Data Standards and Implementation Guide Version MD 20993–0002, 240–402–7911, email:
Catalog. FDA will continue its support 3.1.2, Amendment 1.’’ Received Stephen.Ripley@fda.hhs.gov.
of the newer SDTM Version 1.3 and comments will be placed in the docket
SUPPLEMENTARY INFORMATION:
Version 1.4, which have been listed in and, except for those submitted as
the FDA Data Standards Catalog since ‘‘Confidential Submissions,’’ publicly I. Background
December 2012 and August 2015, viewable at https://www.regulations.gov
respectively. FDA support for SDTM or at the Dockets Management Staff On December 17, 2014, FDA
Version 1.2 will end for studies that between 9 a.m. and 4 p.m., Monday published final guidance for industry
start 12 months after March 15, 2018. through Friday. ‘‘Providing Regulatory Submissions in
DATES: Submit either electronic or • Confidential Submissions—To Electronic Format—Standardized Study
written comments at any time. submit a comment with confidential Data’’ (eStudy Data guidance) posted on
ADDRESSES: You may submit comments information that you do not wish to be FDA’s Study Data Standards Resources
as follows: made publicly available, submit your Web page at https://www.fda.gov/
comments only as a written/paper forindustry/datastandards/studydata
Electronic Submissions standards/default.htm. The eStudy Data
submission. You should submit two
Submit electronic comments in the copies total. One copy will include the guidance implements the electronic
following way: information you claim to be confidential submission requirements of section
• Federal eRulemaking Portal: with a heading or cover note that states 745A(a) of the Federal Food, Drug, and
https://www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS Cosmetic Act (21 U.S.C. 379k–1(a)) for
instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ The study data contained in new drug
Comments submitted electronically, Agency will review this copy, including applications, abbreviated new drug
including attachments, to https:// the claimed confidential information, in applications, biologics license
www.regulations.gov will be posted to its consideration of comments. The applications, and investigational new
the docket unchanged. Because your second copy, which will have the drug applications submitted to CDER or
comment will be made public, you are claimed confidential information CBER by specifying the format for
solely responsible for ensuring that your redacted/blacked out, will be available electronic submissions. The eStudy Data
comment does not include any for public viewing and posted on guidance states that a Federal Register
confidential information that you or a https://www.regulations.gov. Submit notice will specify the transition date
third party may not wish to be posted, both copies to the Dockets Management for updates to standards (with the
such as medical information, your or Staff. If you do not wish your name and month and day for the transition date
anyone else’s Social Security number, or contact information to be made publicly
corresponding to March 15).
confidential business information, such available, you can provide this
as a manufacturing process. Please note information on the cover sheet and not The transition date for the end of FDA
that if you include your name, contact in the body of your comments and you support for SDTM Version 1.2,
information, or other information that must identify this information as Implementation Guide Version 3.1.2,
identifies you in the body of your ‘‘confidential.’’ Any information marked and Implementation Guide Version
comments, that information will be as ‘‘confidential’’ will not be disclosed 3.1.2, Amendment Version 1.2 is March
posted on https://www.regulations.gov. except in accordance with 21 CFR 10.20 15, 2018. Therefore, FDA support for
• If you want to submit a comment and other applicable disclosure law. For SDTM Version 1.2, Implementation
with confidential information that you more information about FDA’s posting Guide Version 3.1.2, and
do not wish to be made available to the of comments to public dockets, see 80 Implementation Guide Version 3.1.2,
public, submit the comment as a FR 56469, September 18, 2015, or access Amendment 1.2 will end for studies that
written/paper submission and in the the information at: https://www.gpo.gov/ start after March 15, 2019. The FDA
manner detailed (see ‘‘Written/Paper fdsys/pkg/FR-2015-09-18/pdf/2015- Data Standards Catalog (see https://
Submissions’’ and ‘‘Instructions’’). 23389.pdf. www.fda.gov/forindustry/data
Written/Paper Submissions Docket: For access to the docket to standards/studydatastandards/
read background documents or the default.htm) will be updated to list
Submit written/paper submissions as
electronic and written/paper comments March 15, 2019, as the ‘‘date support
follows:
received, go to https:// ends.’’
• Mail/Hand delivery/Courier (for
www.regulations.gov and insert the
written/paper submissions): Dockets II. Electronic Access
docket number, found in brackets in the
Management Staff (HFA–305), Food and
heading of this document, into the Persons with access to the internet
Drug Administration, 5630 Fishers
‘‘Search’’ box and follow the prompts
Lane, Rm. 1061, Rockville, MD 20852. may obtain the referenced material at
and/or go to the Dockets Management
• For written/paper comments https://www.fda.gov/forindustry/data
Staff, 5630 Fishers Lane, Rm. 1061,
submitted to the Dockets Management standards/studydatastandards/
Rockville, MD 20852.
Staff, FDA will post your comment, as default.htm.
well as any attachments, except for FOR FURTHER INFORMATION CONTACT:
Dated: August 29, 2017.
information submitted, marked and Fatima Frye, Center for Drug Evaluation
identified, as confidential, if submitted and Research, Food and Drug Leslie Kux,
as detailed in ‘‘Instructions.’’ Administration, 10903 New Hampshire Associate Commissioner for Policy.
sradovich on DSK3GMQ082PROD with NOTICES
Instructions: All submissions received Ave., Bldg. 51, Rm. 1192, Silver Spring, [FR Doc. 2017–18566 Filed 8–31–17; 8:45 am]
must include the Docket No. FDA– MD 20993–0002, 301–796–4863, email: BILLING CODE 4164–01–P
2017–N–4302 for ‘‘Electronic Study cder-edata@fda.hhs.gov; or Stephen
Data Submission; Data Standards, Ripley, Center for Biologics Evaluation
Support End Date for Study Data and Research, Food and Drug
Tabulation Model Version 1.2, Administration, 10903 New Hampshire
Implementation Guide Version 3.1.2, Ave., Bldg. 71, Rm. 7268, Silver Spring,
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Document Created: 2017-09-01 01:50:38
Document Modified: 2017-09-01 01:50:38
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments at any time. | |
| Contact | Fatima Frye, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1192, Silver Spring, MD 20993-0002, 301- 796-4863, email: [email protected]; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7268, Silver Spring, MD 20993-0002, 240-402-7911, email: [email protected] | |
| FR Citation | 82 FR 41624 |
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